Fresenius 5008 & 5008S haemodialysis machines – low risk of inadequate fluid removal during treatment (MDA/2019/018)
Manufactured by Fresenius Medical – inadequate ultrafiltration can occur due to sudden failure of the ultrafiltration (UF) pump.
Action
Staff responsible for patient care:
- Ensure that operators of these machines have read this notice and are alerted to the potential risk of inadequate fluid removal without the machine’s alarm sounding. Consider updating associated user guidance documents for these machines.
- Consider checks after each dialysis treatment to ensure that enough fluid has been removed.
- If you observe frequent episodes of inadequate fluid removal by these machines, notify your local technical/EMBE staff or the manufacturer. This will be noticeable if patient weight is frequently heavier than expected after treatment.
Staff responsible for maintenance of these machines:
- Quarantine the machine if you observe frequent unexplained episodes of inadequate fluid removal.
- Contact the manufacturer to arrange replacement of the ultrafiltration (UF) pump.
- Consider including an additional periodic UF accuracy check as part of the machine’s planned maintenance checks.
lf you are a home patient:
- Contact your healthcare provider for further advice if you have concerns.
Report adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: [England](https://yellowcard.mhra.gov.uk/, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.
Action by
All staff responsible for using and maintenance of haemodialysis equipment.
Deadlines for actions
Actions underway: 10 May 2019 Actions complete: 21 June 2019
Background
MHRA has been made aware of the risk of inadequate fluid removal during treatment due to the failure of the ultrafiltration (UF) pump, which cannot be identified during the manufacturer’s technical safety checks. This failure can happen suddenly, without the machine alarming, and currently can only be identified by observing incomplete fluid removal from patients after dialysis treatments.
Manufacturer contacts
Fresenius Medical Care (UK) Ltd.
Tel: 01623 445 100
Distribution
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and NICAS liaison officers for onward distribution to all relevant staff including:
- Adult intensive care units
- Biomedical engineering staff
- EBME departments
- Haemodialysis nurses
- Haemodialysis units
- Health and safety managers
- Hospital at home units
- In-house maintenance staff
- Medical directors
- Nursing executive directors
- Paediatric intensive care units
- Renal medicine departments
- Renal medicine, directors of
- Special care baby units
- Staff supporting patients receiving haemodialysis at home
Independent distribution
Establishments registered with the Care Quality Commission (CQC) (England only)
- Hospitals in the independent sector
- Independent treatment centres
Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@mhra.gov.uk and requesting this facility.
Enquiries
England
Send enquiries about this notice to MHRA, quoting reference number MDA/2018/024R or 2018/006/020/081/027.
Technical aspects
Roopa Prabhakar or Jacques Pouget, MHRA
Tel: 020 3080 7293 or 7153
Email: DSS-TM@mhra.gov.uk
Clinical aspects
Devices Clinical Team, MHRA
Tel: 020 3080 7274
Email: dct@mhra.gov.uk>
To report an adverse incident involving a medical device in England use the Yellow Card reporting page
Northern Ireland
Alerts in Northern Ireland are distributed via the NICAS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre, CMO Group,
Department of Health, Social Services and Public Safety
Tel: 028 9052 3868
Email: niaic@health-ni.gov.uk
Northern Ireland Adverse Incident Centre (NIAIC)
Please report directly to NIAIC using the forms on our website.
Scotland
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre,
Health Facilities Scotland,
NHS National Services Scotland
Tel: 0131 275 7575
Email: nss.iric@nhs.net
Reporting adverse incidents in Scotland
NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland.
Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.
Private facilities providing care to private clients report to the Care Inspectorate and MHRA.
Wales
Enquiries in Wales should be addressed to:
Healthcare Quality Division,
Welsh Government
Tel: 02920 823 624 / 02920 825 510
Email: Haz-Aic@wales.gsi.gov.uk
Reporting adverse incidents in Wales
Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).
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